ArticleClinical trials (London, England)2015
Evaluating surrogate endpoints, prognostic markers, and predictive markers: Some simple themes.
Article in Clinical trials (London, England), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
7 citing papers in PubMed.
- Era of surrogate endpoints and accelerated approvals: a comprehensive review on applicability, uncertainties, and challenges from regulatory, payer, and patient perspectives.European journal of clinical pharmacology · 2025Review
- Review
- An alternative trial-level measure for evaluating failure-time surrogate endpoints based on prediction error.Contemporary clinical trials communications · 2019Article
- Constructing treatment selection rules based on an estimated treatment effect function: different approaches to take stochastic uncertainty into account have a substantial effect on performance.BMC medical research methodology · 2019Article
- Evaluating Markers for Guiding Treatment.Journal of the National Cancer Institute · 2016Article
- Biomarkers for immunotherapy in genitourinary malignancies.Urologic oncology · 2016Review
- University of Pennsylvania 7th annual conference on statistical issues in clinical trials: Current issues regarding the use of biomarkers and surrogate endpoints in clinical trials (morning panel discussion).Clinical trials (London, England) · 2015Article
Corrections and comments
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Authors and funding
2 authors.
Funding
Abstract
backgroundA surrogate endpoint is an endpoint observed earlier than the true endpoint (a health outcome) that is used to draw conclusions about the effect of treatment on the unobserved true endpoint. A prognostic marker is a marker for predicting the risk of an event given a control treatment; it informs treatment decisions when there is information on anticipated benefits and harms of a new treatment applied to persons at high risk. A predictive marker is a marker for predicting the effect of treatment on outcome in a subgroup of patients or study participants; it provides more rigorous information for treatment selection than a prognostic marker when it is based on estimated treatment effects in a randomized trial.
methodsWe organized our discussion around a different theme for each topic.
results"Fundamentally an extrapolation" refers to the non-statistical considerations and assumptions needed when using surrogate endpoints to evaluate a new treatment. "Decision analysis to the rescue" refers to use the use of decision analysis to evaluate an additional prognostic marker because it is not possible to choose between purely statistical measures of marker performance. "The appeal of simplicity" refers to a straightforward and efficient use of a single randomized trial to evaluate overall treatment effect and treatment effect within subgroups using predictive markers.
conclusionThe simple themes provide a general guideline for evaluation of surrogate endpoints, prognostic markers, and predictive markers.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.